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Peptide Complex
Fx-5A Safety and Tolerability in Healthy Volunteers
Phase 1
Recruiting
Led By Marcelo J Amar, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or above
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial will test the safety, tolerability, and effects of the drug Fx-5A in healthy adults. Participants will stay in the hospital for 1-2 days and have follow-up visits after they leave.
Who is the study for?
Healthy adults over 18, not pregnant, willing to use birth control and avoid other studies. Excludes those with allergies to Fx-5A components, recent blood donors, kidney or liver issues, uncontrolled hypertension, recent investigational drug use or certain medication/supplement intake.Check my eligibility
What is being tested?
The trial tests the safety and effects of a new heart disease treatment called Fx-5A in healthy volunteers. It involves a hospital stay for monitoring via EKGs and blood tests after receiving an infusion of Fx-5A.See study design
What are the potential side effects?
Potential side effects are not detailed but may include reactions related to the infusion process or ingredients in the peptide complex. Monitoring will assess any changes that could indicate side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the safety and tolerability of the Fx-5A peptide complex.
Secondary outcome measures
Assess the PK and PD of the Fx-5A peptide-lipid complex
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
subjects entered into the trial may go thru a 0-4 weeks screening (Screening Phase). On the Intervention phase, subjects will be followed for 7 days which includes: entry criteria assessments and settling at the inpatient unit on Day 0, a single-dose I.V. infusion with data collection on Day 1 followed by 24 hours monitoring (Day 2), a 7-day and 28-day outpatient follow-up visit (Follow-Up Phase).
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,847 Previous Clinical Trials
47,818,582 Total Patients Enrolled
Marcelo J Amar, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
5 Previous Clinical Trials
318 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been taking supplements or medications for at least 8 weeks, except for birth control pills.I am willing and able to sign a consent form.I am not allergic to any parts of the Fx-5A treatment.I am 18 years old or older.My blood pressure is high and not managed with medication.My kidney or liver function is not normal.Your body mass index (BMI) is 30 or higher.You have allergies or intolerances to eggs or ingredients made from eggs.I have not had a fever or feverish illness in the last 5 days.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being recruited for this experiment at the present time?
"According to the details provided on clinicaltrials.gov, this research is actively seeking enrollees. This scientific investigation was initiated on September 29th 2021 and last edited November 11th 2022."
Answered by AI
Has the Fx-5A peptide complex been granted authorization by the FDA?
"Due to the limited information on safety and efficacy, Fx-5A peptide complex was assigned a score of 1 by Power's team. This is an indication that this medical trial is in its initial Phase 1 stage."
Answered by AI
How many individuals are currently participating in this clinical experiment?
"Affirmative. Clinicaltrials.gov's records indicate that this trial is presently accepting participants, with the first posting on September 29th 2021 and the most recent edit on November 11th 2022. The research project needs 64 volunteers to be recruited from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
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